Apparatus and method for use of RFID catheter intelligence

• US 20070083111A1
• Filed: 10/12/2005
• Published: 04/12/2007
• Est. Priority Date: 10/12/2005
• Status: Active Grant

• Current Assignee: Volcano Corporation (Koninklijke Philips N.V.)
• Original Assignee: Volcano Corporation (Koninklijke Philips N.V.)
• Inventors: Hossack, Norman Hugh, Davies, Stephen, Smith, Peter, Klosinski, Richard, Mamayek, Donald, Fry, Stephen, Ahmed, Masood, Brownlie, Scott, Huennekens, Richard Scott, Klingensmith, Jon, Litzza, Gerald, Oliver, Edward, Mott, Eric
• Granted Patent: US 7,988,633 B2
• Time in Patent Office: Days
• US Class Current: 600/437
• CPC Class Codes: A61B 1/00059 provided with identification means for the endoscope
• CPC Class Codes: A61B 2090/0803 Counting the number of times an instrument is used
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4438 Means for identifying the diagnostic device, e.g. barcodes
• CPC Class Codes: A61B 8/4472 Wireless probes
• CPC Class Codes: G06K 19/07749 the record carrier being capable of non-contact communication, e.g. constructional details of the antenna of a non-contact smart card

Abstract

A method and system is provided for using backscattered data and known parameters to characterize vascular tissue. Specifically, methods and devices for identifying information about the imaging element used to gather the backscattered data are provided in order to permit an operation console having a plurality of Virtual Histology classification trees to select the appropriate VH classification tree for analyzing data gathered using that imaging element. In order to select the appropriate VH database for analyzing data from a specific imaging catheter, it is advantageous to know information regarding the function and performance of the catheter, such as the operating frequency of the catheter and whether it is a rotational or phased-array catheter. The present invention provides a device and method for storing this information on the imaging catheter and communicating the information to the operation console. In addition, information related to additional functions of the catheter may also be stored on the catheter and used to further optimize catheter performance and/or select the appropriate Virtual Histology classification tree for analyzing data from the catheter imaging element.

Claims

1. A method of identifying a catheter comprising:

attaching a catheter to a catheter interface device wherein the catheter further comprises an RFID chip located on the proximal end of the catheter and wherein the catheter interface device further comprises an RFID scanner;

reading information related to the function of the catheter stored on the catheter RFID chip; and

identifying at least at least one characteristic related to the function of the catheter.

2. The method of claim 1, wherein the information related to the function of the catheter is selected from a group consisting of catheter serial number, catheter name, make, or model, calibration coefficients, time gain control, post amp gain, date of first use, date of last use, number of uses, hours of use, boot mode, pulse width, expiration date, number of permissible uses, hours of permissible use, geographic region of permissible use, failure codes, or patient information.

3. The method of claim 1, wherein the catheter interface device is operably connected to an operation console, further comprising the step of relaying the at least one characteristic related to the function of the catheter to the operation console.

4. The method of claim 1, wherein the at least one characteristic is further related to the type or operating frequency of the catheter.

5. The method of claim 3, further comprising the step of relaying additional information related to the function of the catheter to the operation console.

6. The method of claim 3, further comprising the step of updating information related to the function of the catheter on the RFID chip.

7. The method of claim 6, wherein the updating step further comprises the step of downloading updated information related to the function of the catheter from the operation console.

8. The method of claim 1, further comprising the steps of:

inserting the catheter into a patient'"'"'s vasculature;

gathering data regarding the patient'"'"'s vasculature while the catheter is operating;

monitoring catheter operation; and

downloading information related to the catheter operation to the RFID chip.

9. The method of claim 8, further comprising the step of downloading the data regarding a patient'"'"'s vasculature to the catheter RFID chip.

10. The method of claim 8, further comprising the step of downloading patient identification data to the catheter RFID chip.

11. The method of claim 8, wherein monitoring step further comprises monitoring the actual time the catheter was is use and wherein the downloading information related to the catheter operation step further comprises downloading the actual time the catheter was in use to the catheter RFID chip.

12. The method of claim 11, further comprising the steps of:

storing the time of permissible use on the catheter RFID chip;

comparing the actual time of use to the time of permissible use; and

prohibiting subsequent use of the catheter once the time of use is equivalent to the permissible time of use.

13. The method of claim 8, further comprising the steps of monitoring catheter operational failure;

and

downloading data regarding the catheter failure to the catheter RFID chip.

14. The method of claim 13, further comprising the step of prohibiting subsequent use of the catheter based on presence of failure data.

15. The method of claim 8, further comprising the step of storing information related to the catheter operation on the catheter RFID chip.

16. The method of claim 15, wherein information related to the catheter operation stored on the catheter RFID chip is selected from a group consisting of:

calibration coefficients, time gain control, post amp gain, date of first use, date of last use, number of uses, hours of use, boot mode, pulse width, expiration date, number of permissible uses, hours of permissible use, geographic region of permissible use, failure codes, or patient information.

17. The method of claim 15, further comprising the step of using the stored information related to the catheter operation to make a decision regarding subsequent catheter use.

18. A method of identifying an imaging catheter comprising:

attaching an imaging catheter to a catheter interface device wherein the imaging catheter further comprises an imaging element located on the distal end of the catheter and an RFID chip, storing information related to the function of the catheter, located on the proximal end of the catheter and wherein the catheter interface device further comprises an RFID scanner and is operably connected to an operation console;

reading information related to the function of the catheter from the catheter RFID chip;

identifying at least one characteristic relating to the function of the catheter; and

relaying the at least one characteristic relating to the function of the catheter from the RFID scanner to an operation console.

19. The method of claim 18, wherein the information related to the function of the catheter is selected from a group consisting of catheter serial number, catheter name, make, or model, calibration coefficients, time gain control, post amp gain, date of first use, date of last use, number of uses, hours of use, boot mode, pulse width, expiration date, number of permissible uses, hours of permissible use, geographic region of permissible use, failure codes, or patient information.

20. The method of claim 18, wherein the at least one characteristic relating to the function of the catheter is further related to the type or operating frequency of the catheter

21. The method of claim 20, further comprising the step of:

using the characteristic related to the type and frequency of the catheter to select a Virtual Histology classification tree for analyzing image data.

22. The method of claim 20, further comprising the step of relaying additional information related to the function of the catheter to the operation console.

23. The method of claim 22, further comprising the step of using the additional information related to the function of the catheter to make a decision regarding catheter use.

24. The method of claim 22, further comprising the step of:

using the additional information related to the function of the catheter to select a Virtual Histology classification tree for analyzing RF image data.

25. The method of claim 24, further comprising the steps of:

inserting the catheter into a patient'"'"'s vasculature;

gathering RF backscattered data from vascular tissue while the catheter is operating; and

using the Virtual Histology classification tree and the backscattered RF data to generate a Virtual Histology image of the vascular tissue.

26. The method of claim 25, further comprising the step of downloading and storing patient identification information on the catheter RFID chip.

27. The method of claim 25, further comprising the steps of:

monitoring catheter operation; and

downloading and storing information related to the catheter operation to the catheter RFID chip.

28. The method of claim 26, further comprising the step of using information related to the catheter operation to make a decision regarding subsequent catheter use.

29. The method of claim 25, further comprising the step of downloading and storing the Virtual Histology image on the catheter RFID chip.

30. The method of claim 29, further comprising the step of encrypting the data stored on the RFID chip.

31. A intravascular ultrasonic imaging catheter comprising

an elongate tubular member having distal and proximal ends;

an ultrasonic imaging element, configured to operate at one of a plurality of frequencies within a given frequency range, operable within a distal region of the elongate tubular member; and

an RFID chip mounted at the proximal end of the elongate tubular member, wherein the RFID chip is adapted to store information related to the function of the ultrasonic imaging system.

32. The catheter of claim 31, wherein the RFID chip is adapted to store information relating to the type and frequency of the ultrasonic imaging system.

33. The catheter of claim 31, wherein the RFID chip is adapted to store information related to the function of the catheter.

34. The catheter of claim 33, wherein the information related to the function of the catheter is selected from a group consisting of catheter serial number, catheter name, catheter model number, calibration coefficients, time gain control, post amp gain, date of first use, date of last use, number of times used, number of permissible uses, geographic location of permissible use, boot mode, pulse width, expiration date of the catheter.

35. The catheter of claim 31, wherein the RFID chip has a transmission distance of about 0-5 mm.

36. The catheter of claim 31, wherein the RFID chip has a transmission distance of about 5-15 mm.

37. The catheter of claim 31, wherein the RFID chip has a transmission distance of about 15-25 mm.

38. The catheter of claim 31, wherein the RFID chip has a memory of 128 bytes or less.

39. The catheter of claim 31, wherein the RFID chip has a memory of at least 1 K byte.

40. The catheter of claim 31, wherein the RFID chip has a memory of at least 2 K bytes.

41. The catheter of claim 31, wherein the RFID chip has a memory of at least 4 K bytes.

42. A system for identifying catheter performance characteristics comprising:

a catheter having distal and proximal ends and a lumen extending therebetween, wherein a first connector is located on the proximal end;

an RFID chip mounted on the proximal end of the catheter; and

a catheter interface device having a second connector located adapted to be couple to the first connector, wherein the catheter interface device further comprises an RFID scanner located in proximity to the second connector.

43. The system of claim 42, wherein the RFID chip is adapted to store information about the catheter.

44. The system of claim 43, wherein the information is selected from a group consisting of catheter serial number, catheter name, catheter model number, calibration coefficients, time gain control, post amp gain, date of first use, date of last use, number of times used, number of permissible uses, geographic location of permissible use, boot mode, pulse width, expiration date of the catheter.

45. The system of claim 44, wherein the RFID scanner is an RFID reader.

46. The system of claim 45, wherein the RFID scanner is a read/write scanner.

47. The system of claim 46, wherein the catheter interface device further comprises a microprocessor for controlling reading and writing to the RFID chip.

48. The system of claim 44, wherein the catheter interface device is operably connected to an operation console.

49. The system of claim 48, wherein the operation console is connected to the catheter interface device via a serial port.

50. The system of claim 48, wherein the operation console is connected to the catheter interface device via a USB port.

51. The system of claim 48, wherein the operation console further comprises a processor for controlling catheter operation based on information stored on the RFID chip.

52. The system of claim 42, wherein the RFID chip has a transmission distance of about 0-5 mm.

53. The system of claim 42, wherein the RFID chip has a transmission distance of about 5-15 mm.

54. The system of claim 42, wherein the RFID chip has a transmission distance of about 15-25 mm.

55. The system of claim 42, wherein the RFID chip has a memory of 128 bytes or less.

56. The system of claim 42, wherein the RFID chip has a memory of at least 1 K byte.

57. The system of claim 42, wherein the RFID chip has a memory of at least 2 K bytes.

58. The system of claim 42, wherein the RFID chip has a memory of at least 4 K bytes.

59. A system for characterizing vascular tissue data comprising:

a catheter having distal and proximal ends and a lumen extending therebetween, wherein a first connector is located on the proximal end;

an ultrasonic imaging element operably coupled to the distal end of the catheter;

an RFID chip mounted on the proximal end of the catheter;

a catheter interface device having proximal and distal ends and a second connector, wherein the pullback device further comprises a RFID scanner located in proximity to the second connector; and

an operation console operably connected to the catheter interface device comprising a database adapted to store a plurality of Virtual Histology classification trees for characterizing vascular tissue.

60. The system of claim 59, wherein the RFID chip is programmed to store information about the catheter.

61. The system of claim 60, wherein the information is selected from a group consisting of catheter serial number, catheter name, catheter model number, calibration coefficients, time gain control, post amp gain, date of first use, date of last use, number of times used, number of permissible uses, geographic location of permissible use, boot mode, pulse width, expiration date of the catheter.

62. The system of claim 61, wherein the RFID scanner is an RFID reader.

63. The system of claim 62 wherein the RFID scanner is a read/write scanner.

64. The system of claim 63, wherein the catheter interface device further comprises a microprocessor for controlling reading and writing information to the RFID chip.

65. The system of claim 64, wherein the microprocessor further includes instructions for controlling catheter operation based on information received from the RFID chip.

66. The system of claim 61, wherein the operation console is connected to the catheter interface device via a USB port.

67. The system of claim 61, wherein the operation console is connected to the catheter interface device via a serial port.

68. The system of claim 61, wherein the operation console further comprises a processor for controlling catheter operation based on information stored on the RFID chip.

69. The system of claim 59, wherein the RFID chip has a transmission distance of about 0-5 mm.

70. The system of claim 59, wherein the RFID chip has a transmission distance of about 5-15 mm.

71. The system of claim 59, wherein the RFID chip has a transmission distance of about 15-25 mm.

72. The system of claim 59, wherein the RFID chip has a memory of 128 bytes or less.

73. The system of claim 59, wherein the RFID chip has a memory of at least 1 K byte.

74. The system of claim 59, wherein the RFID chip has a memory of at least 2 K bytes.

75. The system of claim 59, wherein the RFID chip has a memory of at least 4 K bytes.

76. The system of claim 59, wherein at least one of the Virtual Histology classification trees is stored on the RFID chip.

77. The system of claim 59, wherein the RFID chip further includes a unique security code.

78. The system of claim 59, wherein the RFID chip is encrypted

79. The system of claim 59, wherein the RFID chip further includes information regarding other imaging modalities contained on the catheter.

80. A system for characterizing vascular tissue data comprising:

a catheter further comprising;

an ultrasonic imaging element operable within a distal region of the catheter; and

a communication device for transmitting information about the catheter;

an operation console further comprising

a memory arranged to store a plurality of Virtual Histology classification trees; and

a processor adapted to receive information from the catheter and select a Virtual Histology classification tree based on the information from the catheter.

81. The system of claim 80, wherein the catheter further comprises a memory arranged to store information about the catheter.

82. The system of claim 81, wherein the information about the catheter is selected from a group consisting of catheter serial number, catheter name, make, or model, calibration coefficients, time gain control, post amp gain, date of first use, date of last use, number of uses, hours of use, boot mode, pulse width, expiration date, number of permissible uses, hours of permissible use, geographic region of permissible use, failure codes, or patient information.

83. The system of claim 80, wherein the plurality of classification trees further comprises at least a first classification tree which represents data derived from a rotational IVUS catheter and at least a second classification tree which represents data derived from a phased array IVUS catheter.

84. The system of claim 80, wherein the plurality of classification trees further comprises at least a first classification tree which represents data derived from an IVUS catheter having a first operating frequency and at least a second classification tree which represents data derived from an IVUS catheter having a different operating frequency from the first operating frequency.

85. The system of claim 84, wherein the catheter further comprises a memory arranged to store information regarding the catheter operating frequency and wherein the processor is adapted to select the classification tree based on the catheter operating frequency.

86. The system of claim 80, further comprising a catheter interface device wherein the proximal end the catheter is operably connected to the catheter interface device and the operation console is operably connected to the catheter interface device further comprising:

a first communication connected adapted for receiving and transmitting information from the catheter; and

a second communication connection adapted for receiving and transmitting information from the operation console.

87. The system of claim 86, wherein the catheter interface device further comprises a processor adapted to transfer information from the operation console to the catheter.